BS EN ISO 80369-1:2010

BSI Standards Publication

Small bore connectors for

liquids and gases in healthcare
applications
Part 1: General requirements (ISO
80369-1:2010)
BS EN ISO 80369-1:2010 BRITISH STANDARD

National foreword
This British Standard is the UK implementation of EN ISO
80369-1:2010. It supersedes BS EN 15546-1:2008 which is withdrawn.
The UK participation in its preparation was entrusted to Technical
Committee CH/210/5, Small Bore Connectors for Medical Devices.
A list of organizations represented on this committee can be
obtained on request to its secretary.
This publication does not purport to include all the necessary
provisions of a contract. Users are responsible for its correct
application.
© BSI 2011
ISBN 978 0 580 60941 1
ICS 11.040.10; 11.040.20
Compliance with a British Standard cannot confer immunity from
legal obligations.
This British Standard was published under the authority of the
Standards Policy and Strategy Committee on 31 July 2011.
Amendments issued since publication
Date Text affected
EUROPEAN STANDARD EN ISO 80369-1
NORME EUROPÉENNE
EUROPÄISCHE NORM December 2010

ICS 11.040.10; 11.040.20 Supersedes EN 15546-1:2008

English version

Small bore connectors for liquids and gases in healthcare

applications - Part 1: General requirements (ISO 80369-1:2010)

Raccords de petite taille pour liquides et gaz utilisés dans Verbindungsstücke mit kleinem Durchmesser für
le domaine de la santé - Partie 1: Exigences générales Flüssigkeiten und Gase in medizinischen Anwendungen -
(ISO 80369-1:2010) Teil 1: Allgemeine Anforderungen (ISO 80369-1:2010)

This European Standard was approved by CEN on 14 December 2010.

CEN and CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving
this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning
such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN and CENELEC
member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN and CENELEC member into its own language and notified to the CEN-CENELEC Management Centre
has the same status as the official versions.

CEN and CENELEC members are the national standards bodies and national electrotechnical committees of Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United
Kingdom.

CEN Management Centre: CENELEC Central Secretariat:

Avenue Marnix 17, B-1000 Brussels Avenue Marnix 17, B-1000 Brussels

© 2010 CEN/CENELEC All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 80369-1:2010 E
worldwide for CEN national Members and for CENELEC
Members.
BS EN ISO 80369-1:2010
EN ISO 80369-1:2010 (E)

Foreword
This document (EN ISO 80369-1:2010) has been prepared by Technical Committee ISO/TC 210 "Quality
management and corresponding general aspects for medical devices" in collaboration with Technical
Committee CEN/CLC/TC 3 “Quality management and corresponding general aspects for medical devices” the
secretariat of which is held by NEN.

This European Standard shall be given the status of a national standard, either by publication of an identical
text or by endorsement, at the latest by June 2011, and conflicting national standards shall be withdrawn at
the latest by June 2011.

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.

This document supersedes EN 15546-1:2008.

This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directive.

For relationship with EU Directive, see informative Annex ZA, which is an integral part of this document.

Compared to EN 15546-1:2008 the following changes were implemented:

a) Clause 3 "Terms and definitions" has been editorially revised and amended by the terms "accessory",
"breathing system", "non-interconnectable", "patient" and "responsible organization". The terms "risk" and
"safety" have been cancelled and replaced by a general reference to the appropriate terms given in EN
ISO 14971 and IEC 62366;

b) Clause 4 on materials has been amended by a reference to two ASTM standards for tests on conformity;

c) Clause 5 on the requirements has been completely revised and amended by a sub-section on
incompatibility;

d) A new Clause 6 on additional applications has been added;

e) Clause 7 (respectively Clause 6 in EN 15546-1) on the assessment of new designs (validation) has been
completely revised, more detailed in the structure and amended. Especially the sections on the proposal
initiation (7.2) and on the procedure to assess acceptability and non-interconnectable characteristics (7.3)
have been stated more detailed;

f) Annex A "Rationale" has been completely revised by providing the reasons for this standard by clauses.
In addition the Table A.1 on risk analysis of possible misconnections has been cancelled;

g) A new Annex B "Mechanical tests for verifying non-interconnectable characteristics" has been added;

h) Annex C "Applications" (respectively Clause B in EN 15546-1) has been editorially revised;

i) Annex C "Small bore connectors for vascular systems applications" of EN 15546-1 has been cancelled;

j) A new Annex D "Reference to the Essential Principles" according ISO/TR 16142 has been added;

k) Annex ZA on the relationship to the Medical Device Directive (93/42/EWG) has been aligned;

l) The Bibliography has been updated and amended;

3
 BS EN ISO 80369-1:2010
EN ISO 80369-1:2010 (E)

m) A new clause Terminology has been added at the end of the standard;

n) Editorial revision in alignment with the overtaking of the original European Standard into an International
Standard.

According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.

Endorsement notice

The text of ISO 80369-1:2010 has been approved by CEN as a EN ISO 80369-1:2010 without any
modification.

4
BS EN ISO 80369-1:2010
EN ISO 80369-1:2010 (E)

Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC
This European Standard has been prepared under a mandate given to CEN by the European Union and the
European Free Trade Association to provide a means to conforming to Essential Requirements of the New
576 Approach Directive 93/42/EEC, Council Directive of 14 June 1993 on the approximation of the laws of the
Member States concerning medical devices” (Medical Device Directive).

Once this document is cited in the Official Journal of the European Union under that Directive and has been
implemented as a national standard in at least one Member State, compliance with the clauses of this
document given in Table ZA.1, within the limits of the scope of this document, a presumption of conformity
with the corresponding Essential Requirements of that Directive and associated EFTA regulations.

Table ZA.1 — Correspondence between this European Standard and Directive 93/42/EEC

Corresponding Essential
Clause/subclause
Requirement Qualifying remarks/notes
of this Document
of Directive 93/42/EEC

all 1, 2
4, 5 7.5, 7.6, 9.1, 12.7.4
6 6 a, 7.5, 7.6, 9.1, 12.7.4

WARNING: Other requirements and other EU Directives may be applicable to the products falling within the
585 scope of this International Standard.

5
 BS EN ISO 80369-1:2010
ISO 80369-1:2010(E)

Contents Page

Foreword ............................................................................................................................................................iv
Introduction.........................................................................................................................................................v
1 Scope ......................................................................................................................................................1
2 Normative references............................................................................................................................2
3 Terms and definitions ...........................................................................................................................2
4 Materials used for SMALL-BORE CONNECTORS ........................................................................................3
5 Requirements for SMALL-BORE CONNECTORS for specific APPLICATIONS ..............................................4
5.1 SMALL-BORE CONNECTOR incompatibility...............................................................................................4
5.2 BREATHING SYSTEMS and driving gases APPLICATIONS ..........................................................................4
5.3 Enteral and gastric APPLICATIONS..........................................................................................................4
5.4 Urethral and urinary APPLICATIONS........................................................................................................4
5.5 Limb cuff inflation APPLICATIONS ...........................................................................................................4
5.6 Neuraxial APPLICATIONS ..........................................................................................................................5
5.7 Intravascular or hypodermic APPLICATIONS .........................................................................................5
5.8 Alternative SMALL-BORE CONNECTORS ....................................................................................................5
6 Additional SMALL-BORE CONNECTOR APPLICATIONS .................................................................................5
7 PROCEDURE to assess a proposed new design of SMALL-BORE CONNECTOR for inclusion in
this series of standards ........................................................................................................................6
7.1 General ...................................................................................................................................................6
7.2 Proposal initiation .................................................................................................................................6
7.3 PROCEDURE to assess acceptability and NON-INTERCONNECTABLE characteristics............................6
7.3.1 Design.....................................................................................................................................................6
7.3.2 Design realization..................................................................................................................................6
7.3.3 Design VERIFICATION ...............................................................................................................................7
7.3.4 Design validation...................................................................................................................................7
7.4 Design review ........................................................................................................................................7
7.5 Subsequent parts of this series of standards ....................................................................................7
Annex A (informative) Rationale........................................................................................................................8
Annex B (normative) Mechanical tests for verifying NON-INTERCONNECTABLE characteristics...................11
Annex C (informative) APPLICATIONS of SMALL-BORE CONNECTORS .................................................................12
Annex D (informative) Reference to the Essential Principles ......................................................................14
Bibliography......................................................................................................................................................16
Terminology – Alphabetized index of defined terms....................................................................................17

© ISO 2010 – All rights reserved iii

BS EN ISO 80369-1:2010
ISO 80369-1:2010(E)

Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.

International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.

The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.

ISO 80369-1 was prepared by a Joint Working Group of Technical Committee ISO/TC 210, Quality
management and corresponding general aspects for medical devices, IEC/TC 62, Electrical equipment,
Subcommittee SC D, Electrical equipment in medical practice and CEN/CENELEC TC 3/WG 2, Small-bore
connectors.

ISO 80369 consists of the following parts, under the general title, Small-bore connectors for liquids and gases
in healthcare applications:

⎯ Part 1: General requirements

The following parts are under preparation:

⎯ Part 2: Connectors for breathing systems and driving gases applications

⎯ Part 3: Connectors for enteral applications

⎯ Part 4: Connectors for urethral and urinary applications

⎯ Part 5: Connectors for limb cuff inflation applications

⎯ Part 6: Connectors for neuraxial applications

⎯ Part 7: Connectors for intravascular or hypodermic applications

iv © ISO 2010 – All rights reserved

 BS EN ISO 80369-1:2010
ISO 80369-1:2010(E)

Introduction
In the 1990s concern grew regarding the proliferation of MEDICAL DEVICES fitted with Luer CONNECTORS and the
reports of PATIENT death or injury arising from misconnections that resulted in the inappropriate delivery of
enteral solutions, intrathecal medication or compressed gases.

Concerns regarding the use of Luer CONNECTORS with enteral feeding tubes and gas sampling and gas
delivery systems were raised with CEN/BT and the European Commission. In November 1997 the newly
created CHeF steering group set up a Forum Task Group (FTG) to consider the problem.

The FTG produced CEN Report CR 13825, in which they concluded that there is a problem arising from the
use of a single CONNECTOR design to a number of incompatible APPLICATIONS. In a coronary care unit there are
as many as 40 Luer CONNECTORS on the MEDICAL DEVICES used with a single PATIENT. Therefore it is not
surprising that misconnections are made.

MEDICAL DEVICES have for many years followed the established principle of “safety under single fault
conditions”. Simply stated this means that a single fault should not result in an unacceptable RISK. This
principle is embodied in the requirements of numerous MEDICAL DEVICE standards. Extending this principle to
the application of Luer CONNECTORS, i.e. that misconnection should not result in an unacceptable RISK to a
PATIENT, the FTG recommended that the Luer CONNECTOR should be restricted to MEDICAL DEVICES intended to
be connected to the vascular system or a hypodermic syringe. In addition, new designs of SMALL-BORE
CONNECTORS should be developed for other APPLICATIONS, and these should be NON-INTERCONNECTABLE with
Luer CONNECTORS and each other.

ISO/TR 16142:2006 addresses this type of problem in Essential Principle A.1.2:

The solutions adopted by the manufacturer for the design and construction of the devices should
conform to safety principles, taking into account the generally acknowledged state of the art.

In selecting the most appropriate solutions, the manufacturer should apply the following principles
in the following order:

— identify hazards and the associated risks arising from the intended use and foreseeable
misuse;

— eliminate or reduce risks as far as possible (inherently safe design and construction);

It is understood that SMALL-BORE CONNECTOR systems cannot be designed to overcome all chances of
misconnection or to eliminate deliberate misuse. However, a number of steps that would improve the current
situation and lead to greater PATIENT safety can be taken. This will only be achieved through a long-term
commitment involving industry, healthcare professionals, MEDICAL DEVICE purchasers and MEDICAL DEVICE
regulatory authorities.

This is the first edition of ISO 80369-1 and it cancels and replaces EN 15546-1:2008 which has been
editorially revised.

Part 1 of this International Standard and its parts are intended to be the reference documents in which the
necessary measures and PROCEDURES to prevent misconnection between SMALL-BORE CONNECTORS used in
different APPLICATIONS and designs of SMALL-BORE CONNECTORS for APPLICATIONS are listed. The JWG of
ISO/TC 210 – IEC 62D and CEN/CENELEC TC 3/WG 2 is developing this series of standards in such a way
that ISO 80369-1 includes general requirements to prevent misconnections between SMALL-BORE CONNECTORS
used in different APPLICATIONS.

© ISO 2010 – All rights reserved v

BS EN ISO 80369-1:2010
ISO 80369-1:2010(E)

This part 1 of this International Standard contains general requirements to ensure the prevention of
misconnection between SMALL-BORE CONNECTORS used in different APPLICATIONS. Subsequent parts of this
series of standards are expected to include requirements with regard to the CONNECTORS used in different
APPLICATION categories.

In this standard, the following print types are used:

⎯ Requirements and definitions: roman type.

⎯ Informative material appearing outside of tables, such as notes, examples and references: in smaller type. Normative
text of tables is also in a smaller type.

⎯ TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS NOTED: SMALL
CAPITALS TYPE.

In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination of
the conditions is true.

The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC Directives,
Part 2. For the purposes of this standard, the auxiliary verb:

⎯ “shall” means that compliance with a requirement or a test is mandatory for compliance with this
standard;

⎯ “should” means that compliance with a requirement or a test is recommended but is not mandatory for
compliance with this standard;

⎯ “may” is used to describe a permissible way to achieve compliance with a requirement or test.

An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates that
there is guidance or rationale related to that item in Annex A.

The attention of Member Bodies and National Committees is drawn to the fact that equipment
MANUFACTURERS and testing organizations may need a transitional period following publication of a new,
amended or revised ISO or IEC publication in which to make products in accordance with the new
requirements and to equip themselves for conducting new or revised tests. It is the recommendation of the
committee that the content of this publication be adopted for implementation nationally not earlier than 3 years
from the date of publication for equipment newly designed and not earlier than 5 years from the date of
publication for equipment already in production.

vi © ISO 2010 – All rights reserved

 BS EN ISO 80369-1:2010
INTERNATIONAL STANDARD ISO 80369-1:2010(E)

Small-bore connectors for liquids and gases in healthcare

applications —
Part 1:
General requirements

1 Scope
This part of ISO 80369 specifies general requirements for SMALL-BORE CONNECTORS, which convey liquids or
gases in healthcare APPLICATIONS. These SMALL-BORE CONNECTORS are used in MEDICAL DEVICES or
ACCESSORIES intended for use with a PATIENT.

This International Standard also specifies the healthcare fields in which these SMALL-BORE CONNECTORS are
intended to be used.

These healthcare fields of use include, but are not limited to, APPLICATIONS for:

⎯ BREATHING SYSTEMS and driving gases,

⎯ enteral and gastric,

⎯ urethral and urinary,

⎯ limb cuff inflation,

⎯ neuraxial devices, and

⎯ intravascular or hypodermic.

SMALL-BORE CONNECTORS as specified in this International Standard are NON-INTERCONNECTABLE with:

⎯ the cones and sockets of ISO 5356-1:2004 and ISO 5356-2:2006;

⎯ the temperature sensor CONNECTOR and mating ports specified in Annex DD of ISO 8185:2007; and

⎯ the nipples of EN 13544-2:2002.

This International Standard provides the methodology to assess NON-INTERCONNECTABLE characteristics of

SMALL-BORE CONNECTORS based on their inherent design and dimensions in order to reduce the RISK of
misconnections between MEDICAL DEVICES or between ACCESSORIES for different APPLICATIONS and to reduce
the RISK of misconnections between MEDICAL DEVICES with 6 % Luer CONNECTORS, and all other non-Luer
CONNECTORS that will be developed under future parts of this series of standards.

It does not specify requirements for the MEDICAL DEVICES or ACCESSORIES that use these SMALL-BORE
CONNECTORS. Such requirements are given in particular International Standards for specific MEDICAL DEVICES
or ACCESSORIES.

NOTE 1 It is intended that new designs of SMALL-BORE CONNECTORS will be included in this series of standards after
they have been assessed according to the PROCEDURE given in Clause 6.

© ISO 2010 – All rights reserved 1

BS EN ISO 80369-1:2010
ISO 80369-1:2010(E)

NOTE 2 MANUFACTURERS are encouraged to incorporate the SMALL-BORE CONNECTORS specified in this series of
standards into MEDICAL DEVICES, medical systems or ACCESSORIES, even if currently not required by the relevant particular
MEDICAL DEVICE standards. It is expected that when the relevant particular MEDICAL DEVICE standards are revised,
requirements for SMALL-BORE CONNECTORS as specified in the series of standards will be included.

NOTE 3 MANUFACTURERS and RESPONSIBLE ORGANIZATIONS are encouraged to report their experience with the SMALL-
BORE CONNECTORS specified in this series of standards to the Secretariat of ISO/TC 210 to consider this feedback during
the revision of the relevant part of this series of standards.

2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.

ISO 5356-1:2004, Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets

ISO 5356-2:2006, Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded
weight-bearing connectors

ISO 14971:2007, Medical devices — Application of risk management to medical devices

EN 13544-2:2002, Respiratory therapy equipment — Part 2: Tubing and connectors

IEC 62366:2007, Medical devices — Application of usability engineering to medical devices

3 Terms and definitions

For the purposes of this document, the terms and definitions specified in ISO 14971:2007, IEC 62366:2007
and the following apply. For convenience, the sources of all defined terms used in this document are given in
an index on page 17.

3.1
ACCESSORY
additional part(s) for use with MEDICAL DEVICE in order to:

⎯ achieve the INTENDED USE,

⎯ adapt it to some special use,

⎯ facilitate its use,

⎯ enhance its performance, or

⎯ enable its functions to be integrated with those of other MEDICAL DEVICES

[Modified from IEC 60601-1:2005, definition 3.3]

3.2
APPLICATION
specific healthcare field in which a SMALL-BORE CONNECTOR is intended to be used

NOTE Annex C lists SMALL-BORE CONNECTOR APPLICATIONS.

3.3
BREATHING SYSTEM
inspiratory and expiratory pathways through which gas flows at respiratory pressures and bounded by the port
through which fresh gas enters, the PATIENT CONNECTION port and the exhaust port

2 © ISO 2010 – All rights reserved

 BS EN ISO 80369-1:2010
ISO 80369-1:2010(E)

3.4
CONNECTION
union or joining of mating halves of a CONNECTOR

3.5
CONNECTOR
mechanical device, consisting of one of two mating halves and designed to join a conduit to convey liquids or
gases

3.6
NON-INTERCONNECTABLE
having characteristics which incorporate geometries or other characteristics that prevent different
CONNECTORS from being connected

3.7
PATIENT
person undergoing a medical, surgical or dental PROCEDURE

[Modified from IEC 60601-1:2005, definition 3.76]

3.8
RESPONSIBLE ORGANIZATION
entity accountable for the use and maintenance of a MEDICAL DEVICE

NOTE 1 The accountable entity can be, for example, a hospital, an individual clinician or a layperson. In home use
applications, the PATIENT, USER and RESPONSIBLE ORGANIZATION can be one and the same person.

NOTE 2 Education and training is included in “use.”

[Modified from IEC 60601-1:2005, definition 3.101]

3.9
RIGID MATERIAL
material with a modulus of elasticity either in flexure or in tension greater than 35 000 kg/cm2 (3 433 MPa)

3.10
SEMI-RIGID MATERIAL
material with a modulus of elasticity either in flexure or in tension, between 700 kg/cm2 and 35 000 kg/cm2
(69 MPa and 3 433 MPa)

3.11
SMALL-BORE
inner-fluid pathway of a CONNECTION with a diameter less than 8,5 mm

NOTE For the purposes of this standard, the 8,5 mm cone and socket of ISO 5356-1 is not considered a SMALL-BORE
CONNECTOR.

4 Materials used for SMALL-BORE CONNECTORS

A SMALL-BORE CONNECTOR shall be made of RIGID MATERIAL or SEMI-RIGID MATERIAL.

Check compliance by application of the tests of ASTM D747 or ASTM D790 at (23 ± 2) °C and (50 ± 5) %
relative humidity.

© ISO 2010 – All rights reserved 3

BS EN ISO 80369-1:2010
ISO 80369-1:2010(E)

5 Requirements for SMALL-BORE CONNECTORS for specific APPLICATIONS

5.1 SMALL-BORE CONNECTOR incompatibility

SMALL-BORE CONNECTORS of each APPLICATION category specified in this International Standard shall be NON-
INTERCONNECTABLE with any of the SMALL-BORE CONNECTORS of every other APPLICATION category for RISKS to
be acceptable, unless otherwise indicated.

SMALL-BORE CONNECTORS for APPLICATION categories specified in this International Standard shall be NON-
INTERCONNECTABLE with:

⎯ the cones and sockets of ISO 5356-1:2004 and ISO 5356-2:2006; and

⎯ the nipples of EN 13544-2:2002;

⎯ the temperature sensor CONNECTOR and mating ports specified in Annex DD of ISO 8185:2007;

unless otherwise indicated.

Check compliance by confirming that OBJECTIVE EVIDENCE verifies that RISKS have been reduced to acceptable
levels for the acceptability criteria specified in Annex B and other acceptability criteria established by the
MANUFACTURER for NON-INTERCONNECTABLE characteristics. Verify that the SMALL-BORE CONNECTOR is NON-
INTERCONNECTABLE.

5.2 BREATHING SYSTEMS and driving gases APPLICATIONS

SMALL-BORE CONNECTORS intended to be used either as an ancillary port CONNECTION in a BREATHING SYSTEM
or a respirable driving gas APPLICATION of MEDICAL DEVICES and ACCESSORIES shall comply with
ISO 80369-2:—, unless the use of these CONNECTORS creates an unacceptable RISK for a specific MEDICAL
DEVICE, or shall comply with 5.8.

Check compliance by inspection of the RISK MANAGEMENT FILE for a specific MEDICAL DEVICE or application of
the tests of ISO 80369-2:—. See also 5.8 for alternative methods of compliance.

5.3 Enteral and gastric APPLICATIONS

SMALL-BORE CONNECTORS intended to be used for CONNECTIONS in enteral and gastric APPLICATIONS shall
comply with ISO 80369-3:—, unless the use of these CONNECTORS creates an unacceptable RISK for a specific
MEDICAL DEVICE or shall comply with 5.8.

Check compliance by inspection of the RISK MANAGEMENT FILE for a specific MEDICAL DEVICE or application of
the tests of ISO 80369-3:—. See also 5.8 for alternative methods of compliance.

5.4 Urethral and urinary APPLICATIONS

SMALL-BORE CONNECTORS intended to be used for CONNECTIONS in urethral and urinary APPLICATIONS shall
comply with ISO 80369-4:— or 5.8, unless the use of these CONNECTORS creates an unacceptable RISK for a
specific MEDICAL DEVICE or shall comply with 5.8.

Check compliance by inspection of the RISK MANAGEMENT FILE for a specific MEDICAL DEVICE or application of
the tests of ISO 80369-4:—. See also 5.8 for alternative methods of compliance.

5.5 Limb cuff inflation APPLICATIONS

SMALL-BORE CONNECTORS intended to be used for CONNECTIONS in limb cuff inflation APPLICATIONS shall comply
with ISO 80369-5:—, unless the use of these CONNECTORS creates an unacceptable RISK for a specific
MEDICAL DEVICE or shall comply with 5.8.

4 © ISO 2010 – All rights reserved

 BS EN ISO 80369-1:2010
ISO 80369-1:2010(E)

Check compliance by inspection of the RISK MANAGEMENT FILE for a specific MEDICAL DEVICE or application of
the tests of ISO 80369-5:—. See also 5.8 for alternative methods of compliance.

5.6 Neuraxial APPLICATIONS

SMALL-BORE CONNECTORS intended to be used for CONNECTIONS in neuraxial APPLICATIONS shall comply with
ISO 80369-6:—, unless the use of these CONNECTORS creates an unacceptable RISK for a specific MEDICAL
DEVICE or shall comply with 5.8.

Check compliance by inspection of the RISK MANAGEMENT FILE for a specific MEDICAL DEVICE or application of
the tests of ISO 80369-6:—. See also 5.8 for alternative methods of compliance.

5.7 Intravascular or hypodermic APPLICATIONS

SMALL-BORE CONNECTORS intended to be used for CONNECTIONS in intravascular or hypodermic APPLICATIONS

shall comply with ISO 80369-7:—, unless the use of these CONNECTORS creates an unacceptable RISK for a
specific MEDICAL DEVICE or shall comply with 5.8.

NOTE Upon its publication, ISO 80369-7:— will replace ISO 594-1:1986 and ISO 594-2:1998.

Check compliance by inspection of the RISK MANAGEMENT FILE for a specific MEDICAL DEVICE or application of
the tests of ISO 80369-7:—. See also 5.8 for alternative methods of compliance.

5.8 Alternative SMALL-BORE CONNECTORS

Alternative designs of SMALL-BORE CONNECTORS to those specified in 5.2 to 5.7 may be used in a MEDICAL
DEVICE or ACCESSORY, and if used, they shall:

a) be NON-INTERCONNECTABLE with the CONNECTORS specified in 5.2 through 5.7, inclusive;

b) not create an unacceptable RISK for a specific MEDICAL DEVICE or ACCESSORY;

c) be evaluated according to Annex B; and

d) comply with Clause 4.

Check compliance by confirming that OBJECTIVE EVIDENCE verifies that RISKS have been reduced to acceptable
levels for the acceptability criteria specified in Annex B and other acceptability criteria established by the
MANUFACTURER for NON-INTERCONNECTABLE characteristics for the MEDICAL DEVICE or ACCESSORY.

6 Additional SMALL-BORE CONNECTOR APPLICATIONS

Alternative designs of SMALL-BORE CONNECTORS to those specified in 5.2 to 5.7, which convey liquids or gases,
and which are used in MEDICAL DEVICES and ACCESSORIES intended for use with a PATIENT for other
APPLICATIONS, may be used, and if used, they shall:

a) be NON-INTERCONNECTABLE with the CONNECTORS specified in 5.2 through 5.7, inclusive;

b) not create an unacceptable RISK for a specific MEDICAL DEVICE or ACCESSORY; and

c) be evaluated according to Annex B.

Check compliance by confirming that OBJECTIVE EVIDENCE verifies that RISKS have been reduced to acceptable
levels for the acceptability criteria specified in Annex B and other acceptability criteria established by the
MANUFACTURER for NON-INTERCONNECTABLE characteristics.

© ISO 2010 – All rights reserved 5

BS EN ISO 80369-1:2010
ISO 80369-1:2010(E)

7 PROCEDURE to assess a proposed new design of SMALL-BORE CONNECTOR for

inclusion in this series of standards

7.1 General

Working groups or individuals, including MANUFACTURERS, wishing to include a new design of a SMALL-BORE
CONNECTOR into this family of International Standards, should make this request to ISO/TC 210 according to
the PROCEDURE set out in this clause. ISO/TC 210 shall consider this request and shall determine which
relevant part of this series of standards should be amended or revised, in accordance with ISO and IEC
PROCEDURES.

Groups or individuals submitting a design shall verify that there are no outstanding intellectual property right
issues or, as appropriate, shall declare that they are prepared to license relevant patents, both granted and
pending, which are necessary to manufacture and sell MEDICAL DEVICES that include the submitted design.
Groups or individuals holding patents hereby shall also declare that they are aware of the rules governing
inclusion of patented items in International Standards as described in the appropriate ISO PROCEDURES and
that they are willing to negotiate licenses with an unlimited number of applicants throughout the world under
reasonable and non-discriminatory terms and conditions that are demonstrably free of any unfair competition.

7.2 Proposal initiation

Groups or individuals submitting a new SMALL-BORE CONNECTOR design shall submit to ISO/TC 210 a concept
proposal identifying the targeted APPLICATION category. ISO/TC 210, or a designated working group, shall
evaluate the submitted proposal.

The submitter shall develop the design proposal and shall maintain and supply RECORDS for the evaluation.
The design proposal shall include:

a) a justification for the proposal that includes a description of any CONNECTIONS of concern, which need to
become NON-INTERCONNECTABLE, literature reviews, adverse event information and/or complaint analysis;

b) design requirements that include USER PROFILES, according to IEC 62366:2007, use environments,
USABILITY goals, according to IEC 62366:2007, functional requirements suitable to maintain clinical
performance necessary to achieve freedom from unacceptable RISK, requirements suitable to maintain
NON-INTERCONNECTABLE characteristics, RISK ANALYSIS and results, according to ISO 14971:2007, if any,
from previous similar designs;

c) design specifications, including a USABILITY specification, according to IEC 62366:2007, which satisfy all
aspects of design requirements; it shall include objective evidence that risks have been reduced to
acceptable levels, according to ISO 14971:2007, for the acceptability criteria specified in Annex B; and

d) a completed summary of SMALL-BORE CONNECTOR criteria and requirements for the proposed SMALL-BORE
CONNECTOR design.

7.3 PROCEDURE to assess acceptability and NON-INTERCONNECTABLE characteristics

7.3.1 Design

The submitter shall conduct an engineering analysis of the design of the proposed SMALL-BORE CONNECTOR
using the design details in this series of standards. This evaluation can include, but is not limited to, minimum
and maximum tolerance stack up assessments that compare the proposed design with other existing or
proposed designs of SMALL-BORE CONNECTORS in this series. Computer-assisted design (CAD) drawing
evaluations or other appropriate design feasibility assessment tools may be utilized.

7.3.2 Design realization

The submitter shall produce test samples and carry out testing, as described in 7.3.3 and 7.3.4, to verify that
design requirements and design specifications are met. This PROCESS may be iterative.

6 © ISO 2010 – All rights reserved

 BS EN ISO 80369-1:2010
ISO 80369-1:2010(E)

7.3.3 Design VERIFICATION

The submitter shall verify the design as follows:

a) Select an independent party to carry out design review and VERIFICATION testing.

b) Conduct dimensional analyses, physical testing and MEDICAL DEVICE category-specific performance
testing on sample sizes sufficient to allow statistical analysis of test results. The tests shall verify that
dimensions meet specification and NON-INTERCONNECTABLE characteristics with other SMALL-BORE
CONNECTORS in this series, and that physical performance properties and MEDICAL DEVICE performance
requirements are met. It shall include OBJECTIVE EVIDENCE that RISKS have been reduced to acceptable
levels, according to ISO 14971:2007, for the acceptability criteria specified in Annex B and other
acceptability criteria established for NON-INTERCONNECTABLE characteristics.

c) The potential for misuse, aging and disinfection/sterilization shall be considered.

d) Evidence of design acceptance by clinical USERS of a potential target MEDICAL DEVICE shall be provided.

VERIFICATION reports summarizing the above testing shall be prepared and submitted for consideration to the
technical committee or a designated working group. These reports shall include VERIFICATION results for each
identified design requirement and each element of the design specification.

7.3.4 Design validation

After design VERIFICATION, the submitter shall conduct a design validation assessment. Validation shall assess
the acceptability of production quality SMALL-BORE CONNECTORS in the intended APPLICATION and MEDICAL
DEVICE with a population of USERS in the clinical or simulated environment. The validation shall assess the
NON-INTERCONNECTABLE characteristics of the SMALL-BORE CONNECTOR with the SMALL-BORE CONNECTORS of the
other APPLICATIONS as specified in Clause 5. Conclusions shall be statistically based and demonstrate that
performance objectives have been met.

The design validation shall also include a USABILITY validation according to IEC 62366:2007, 5.9.

7.4 Design review

ISO/TC 210, or a designated working group, shall assign a group with specific technical expertise in the
targeted APPLICATION and MEDICAL DEVICE(S) that are affected, to assess the design and submitted information
resulting from 7.3, and prepare a report to ISO/TC 210 giving its conclusions.

ISO/TC 210 shall decide on the suitability of the proposed SMALL-BORE CONNECTOR for inclusion in this series
of standards for the intended APPLICATION.

7.5 Subsequent parts of this series of standards

If the proposed SMALL-BORE CONNECTOR is suitable for inclusion in this series of standards, ISO/TC 210, or a
designated working group, shall assign the proposal to the relevant working group, which shall initiate the
appropriate steps to include the new design by amendment, revision or creation of the relevant part of this
series of standards.

A summary of the data and reports (see 7.3) shall be prepared as an informative annex to be included as a
rationale in the preparation of the subsequent Standard.

© ISO 2010 – All rights reserved 7

BS EN ISO 80369-1:2010
ISO 80369-1:2010(E)

Annex A
(informative)

Rationale

This Annex provides rationale for the important requirements of this document and is intended for those who
are familiar with the subject of this document but who have not participated in its development. An
understanding of the reasons for the main requirements is considered to be essential for its proper application.
Furthermore, as clinical practice and technology change, it is believed that rationale for the present
requirements will facilitate any revision of this document necessitated by those developments.

The clauses in this annex have been so numbered to correspond to the clauses in this International Standard
to which they refer. The numbering is, therefore, not consecutive.

Clause 1 Scope

Advances in modern medicine have led to a significant rise in the number of MEDICAL DEVICES attached to
PATIENTS. Many of these devices fall into the categories of monitoring devices, diagnostic devices and drug
delivery devices.

Such MEDICAL DEVICES perform a variety of similar, but not interchangeable, functions. Examples include:
intravenous fluid delivery, enteral feeding, respiratory gas sampling, non-invasive blood pressure
measurement and injection of intrathecal medication. Despite the varied nature of the functions performed,
many of these MEDICAL DEVICES use a universal system of SMALL-BORE CONNECTORS based on the 6 % Luer
tapered CONNECTOR as specified in ISO 594-1:1996 and ISO 594-2:1998.

The universal nature of the CONNECTORS used, and the proximity of several different CONNECTORS around a
single PATIENT, makes accidental misconnections inevitable. The consequences of such misconnections vary
but a significant number are actually or potentially fatal.

Serious and usually fatal misconnections include intravenous injection of air, intravenous injection of enteral
feeds and intrathecal injection of vincristine. Less disastrous misconnections such as enteral administration of
intravenous fluids might not directly HARM the PATIENT but cause a failure of the intended administration.

Introducing a series of NON-INTERCONNECTABLE, SMALL-BORE CONNECTORS for MEDICAL DEVICES will help to
reduce the likelihood of misconnections and lead to a direct improvement in PATIENT safety. Any such series
also includes the 6 % Luer which is restricted to CONNECTIONS in vascular APPLICATIONS or with CONNECTIONS
to a hypodermic syringe.

CEN BT TF 123 carried out an extensive RISK ANALYSIS of possible misconnections that might result when the
same CONNECTOR is used in different APPLICATIONS. Reducing the identified unacceptable RISKS is the basis of
this series of standards.

Clause 4 Materials used for SMALL-BORE CONNECTORS

Introducing a series of NON-INTERCONNECTABLE, SMALL-BORE CONNECTORS for MEDICAL DEVICES made from
RIGID MATERIAL or SEMI-RIGID MATERIAL will help to reduce the incidence of misconnections and lead to a direct
improvement in PATIENT safety. RIGID MATERIALS or SEMI-RIGID MATERIALS have been specified to eliminate the
possibility of forcing a fit between incompatible SMALL-BORE CONNECTORS made from flexible materials.

It is understood that SMALL-BORE CONNECTOR systems cannot be designed to overcome all chances of
misconnection or to eliminate deliberate misuse. For example, the possibility of the misconnection of a SMALL-
BORE CONNECTOR to a specialized PATIENT-access port can still exist. Specialized PATIENT-access ports often
require the use of flexible materials which are intended to permit access by a range of MEDICAL DEVICES or
ACCESSORIES, such as, endoscopes, bronchoscopes, and surgical instruments. These access ports can permit
interconnection with some SMALL-BORE CONNECTORS. The RISKS associated with the use of these specialized

8 © ISO 2010 – All rights reserved

 BS EN ISO 80369-1:2010
ISO 80369-1:2010(E)

PATIENT-access ports are not addressed by this standard. MANUFACTURERS of MEDICAL DEVICES or
ACCESSORIES and the committees responsible for the development of standards for MEDICAL DEVICES or
ACCESSORIES that incorporate these specialized PATIENT-access ports will need to assess these RISKS.

Clause 5 Requirements for SMALL-BORE CONNECTORS for specific APPLICATIONS

National regulatory bodies, hospital accreditation organizations, and independent public health organizations
recognize misconnections as a persistent problem with potentially lethal consequences. Warnings have been
issued and strategies offered for healthcare organizations to reduce RISKS and MANUFACTURERS to redesign
CONNECTORS to prevent misconnections. The ability of CONNECTORS used to interconnect is identified as a root
cause of misconnections.

CEN Report CR 13825 identifies possible misconnections among MEDICAL DEVICE functions involving the
conveyance of a gas or liquid for the different APPLICATION categories and classifies each according to the
SEVERITY of the HARM that can occur. The report confirms that the APPLICATION categories specified in this
standard are incompatible i.e., misconnections among these APPLICATION categories can cause serious injury
or death.

The committee reviewed this material and agreed that these APPLICATION categories were the highest areas of
RISK to public health from MEDICAL DEVICE misconnection if a misconnection were to occur. This determination
comes from years of adverse event reports, literature reviews and research on MEDICAL DEVICE misconnection.
It is noted that the identified APPLICATION categories do not encompass all medical areas to which MEDICAL
DEVICES are intended to be used and therefore all potential areas of misconnection might not be addressed by
this document. It is intended that the APPLICATION categories in this clause represent a majority of MEDICAL
DEVICES containing SMALL-BORE CONNECTORS and therefore the use of these SMALL-BORE CONNECTORS will
bring the RISK of misconnection to an acceptable level.

This clause provides the requirements for SMALL-BORE CONNECTORS based upon these APPLICATION categories.
Minimal requirements including verifiable acceptability criteria are established to reduce the RISK of
misconnection. The purpose is to make the RISK of misconnection acceptably low by ensuring that halves of
incompatible CONNECTORS are NON-INTERCONNECTABLE. OBJECTIVE EVIDENCE is required that the criteria are
met for the RISK of misconnection for these criteria to be acceptable.

The requirements are not comprehensive. Additional requirements and criteria for other NON-
INTERCONNECTABLE characteristics can be needed to reduce the RISK of incompatible misconnections to
acceptable levels. This circumstance is acknowledged in the standard by requiring that all RISK acceptability
criteria applicable to NON-INTERCONNECTABLE characteristics be met.

Subclause 5.8 Alternative SMALL-BORE CONNECTORS

As it is not the intent of this standard to prevent the use of alternative designs (proprietary SMALL-BORE
CONNECTORS) within an identified APPLICATION category, this subclause provides the requirements for such
designs to ensure that their use provides the same level of safety in the market without introducing additional
RISK. As the approach of this subclause does not include inspection of the RISK MANAGEMENT FILE by the
committee, but rather the use of force functions as described in Annex B to address NON-INTERCONNECTABILITY,
it is expected that each MANUFACTURER intending to use a proprietary SMALL-BORE CONNECTOR not in this
standard shall establish, validate and maintain their RISK MANAGEMENT FILE to ensure the clinical safety of their
SMALL-BORE CONNECTOR.

Clause 6 Additional SMALL-BORE CONNECTOR APPLICATIONS

This clause provides the requirements for a new SMALL-BORE CONNECTOR design for an APPLICATION not
identified in clause 5. The purpose of this clause is to allow the inclusion of other APPLICATIONS not identified in
this standard for inclusion to this series of standards.

Subclause 7.2 Proposal initiation

The proposal serves two interrelated purposes. One provides justification for a new APPLICATION category and
the other introduces a design for a new SMALL-BORE CONNECTOR for that category. ISO/TC 210 evaluates the

© ISO 2010 – All rights reserved 9

BS EN ISO 80369-1:2010
ISO 80369-1:2010(E)

proposal to determine if a new APPLICATION category is needed and that necessary requirements for the new
SMALL-BORE CONNECTOR for that category have been identified.

The need for a new APPLICATION category can arise by the introduction of a MEDICAL DEVICE for a new medical
APPLICATION or changing conveyance requirements for MEDICAL DEVICES within an existing APPLICATION
category. However, safety is always an important consideration in justifying that need. Thus, justification for a
new medical APPLICATION involving conveyance of a gas or liquid is based on analytical results establishing
the need to prevent CONNECTIONS with the other APPLICATION categories. Those safety concerns are based in
large part on the SEVERITY of the HARM that can occur with misconnections. Thus, the justification involving
changing requirements is based upon RISK ANALYSIS, adverse events, reported complaints, and other relevant
safety issues.

Safety requirements are also important for a new SMALL-BORE CONNECTOR. The RISK of misconnection for a
proposed new SMALL-BORE CONNECTOR is required to be acceptable. New SMALL-BORE CONNECTORS are
designed to be NON-INTERCONNECTABLE between MEDICAL DEVICES or between ACCESSORIES for the different
APPLICATION categories. However, since NON-INTERCONNECTABLE characteristics alone cannot eliminate
misconnections, the use of identified HAZARDS and HAZARDOUS SITUATIONS to establish safety-related USABILITY
goals is also needed to reduce RISKS for the new SMALL-BORE CONNECTOR to an acceptable level. Thus,
OBJECTIVE EVIDENCE is required verifying that acceptability criteria are met and validation is required to assess
the acceptability of NON-INTERCONNECTABLE characteristics under clinical or simulated use conditions.

NON-INTERCONNECTABLE CONNECTORS are expected to easily fall apart after a USER attempts to assemble them
and to prevent the perception that a secure CONNECTION has been made. The very low force of separation of
0,02 N (2 g) was chosen as the lowest haptic detection threshold of secure CONNECTION that can be easily
measured. No additional leak testing is proposed, because a leaking CONNECTION that appears to be a secure
CONNECTION when first assembled is considered by the committee to be an unacceptable RISK.

EXAMPLES RISK of infection, embolism, or hypoxia.

10 © ISO 2010 – All rights reserved

 BS EN ISO 80369-1:2010
ISO 80369-1:2010(E)

Annex B
(normative)

Mechanical tests for verifying NON-INTERCONNECTABLE characteristics

This Annex specifies the criteria and test methods to be used to obtain OBJECTIVE EVIDENCE to demonstrate
NON-INTERCONNECTABLE characteristics between a SMALL-BORE CONNECTOR being evaluated and the other
CONNECTORS likely to be found in the environment around the PATIENT. There can and will be other
CONNECTOR-specific acceptability criteria necessary for NON-INTERCONNECTABLE characteristics such as
specific dimensional or rigidity requirements. They are not addressed in this Annex. However, VERIFICATION
that such other acceptability criteria are met, are required for all such criteria. The test methods used should
be appropriate for those acceptability criteria.

A NON-INTERCONNECTABLE SMALL-BORE CONNECTOR shall not appear to provide a secure CONNECTION when
forcefully assembled to any surface of the components of, and shall easily disengage from each of the
following:

⎯ each SMALL-BORE CONNECTOR of every other APPLICATION category specified in this International Standard
and its parts;

⎯ the nipples of EN 13544-2:2002; and

⎯ the temperature sensor CONNECTOR and mating ports specified in Annex DD of ISO 8185:2007.

For the purposes of this test, the CONNECTORS above, other than the SMALL-BORE CONNECTOR being evaluated,
shall be made of RIGID MATERIAL using nominal dimensions or may be REFERENCE CONNECTORS as specified in
other parts of this standard.

Check compliance with the following test.

a) Condition the CONNECTORS to be assembled at 23 °C ± 2 °C and a relative humidity of 50 % ±5 % for not

less than 1 h.

b) Assemble the SMALL-BORE CONNECTOR to the test CONNECTOR by applying an axial force at a rate of
approximately 10 N/s that does not visibly damage either CONNECTOR, not exceeding 70 N and a torque
not exceeding 0,12 Nm to a limit of no more than 90°. Rotate threaded CONNECTORS in a clockwise
manner. Hold the maximum assembly force for no less than 10 s.

c) After 10 s of engagement, without activation of any latch or disengagement mechanism, apply an axial
force of separation to the assembled CONNECTORS to a maximum 0,02 N (2 g). Verify the assembled
CONNECTORS disengage.

d) If applicable, for threaded CONNECTORS, repeat a) to c) by assembling the CONNECTORS in a counter-

clockwise manner in b).

e) Repeat a) to d) for every potential assembly surface.

NOTE Potential assembly surfaces include any CONNECTION of inside and outside surfaces or inside or outside
diameters on either CONNECTOR which can interconnect and provide the appearance of a secure CONNECTION.

© ISO 2010 – All rights reserved 11

BS EN ISO 80369-1:2010
ISO 80369-1:2010(E)

Annex C
(informative)

APPLICATIONS of SMALL-BORE CONNECTORS

Table C.1 summarizes the categories of APPLICATION of SMALL-BORE CONNECTORS.

Table C.1 — APPLICATIONS of SMALL-BORE CONNECTORS

SMALL-BORE CONNECTOR
APPLICATION category Specific use Examples of MEDICAL Devices
specification

BREATHING SYSTEMS and Ancillary port CONNECTIONS
driving gases that operate at BREATHING
SYSTEM pressures
gas sampling lines for respiratory ISO 80369-2
gas monitoring
lines for BREATHING SYSTEM pressure
measurement
line to control expiratory valve in the
BREATHING SYSTEM

lines to BREATHING SYSTEM from

nebuliser
CONNECTIONS for respirable driving gas to a nebuliser ISO 80369-2
driving gas at pressures
greater than BREATHING
SYSTEM pressures

Limb cuff inflation CONNECTIONS for inflation of
sphygmomanometer cuffs
CONNECTIONS for inflation of
tourniquets
Enteral and gastric CONNECTIONS for access to
the oesophagus or stomach
tubing CONNECTORS for neonatal ISO 80369-5
sphygmomanometers
tubing CONNECTORS for 1-hose ISO 80369-5
paediatric/adult
sphygmomanometers
tubing CONNECTORS for 2-hose ISO 80369-5
paediatric/adult
sphygmomanometers
tubing CONNECTORS for tourniquet ISO 80369-5
devices
enteral feeding sets (nutrition) ISO 80369-3
gravity plus pumped feed
connecting sets
medication ports (Y-ports, T-sets)
enteral tubes
nasal, gastric, duodental, jejunal
percutaneous (PEG, PEJ, buttons)
enteral Pouches
syringes for feeding and enteral
medication administration

12 © ISO 2010 – All rights reserved


APPLICATION category
Neuraxial
Urethral/urinary
Intravascular or
hypodermic
© ISO 2010 – All rights reserved
BS EN ISO 80369-1:2010
ISO 80369-1:2010(E)
Table C.1 (continued)
SMALL-BORE CONNECTOR
Specific use Examples of MEDICAL Devices
specification
CONNECTIONS for access to epi(peri)dural and intrathecal ISO 80369-6
nerves or the nervous (spinal) needles and catheters
system
caudal needles (adult and
paediatric)
introducer needles, drawing up
needles, other needles (e.g. other
nerve blocks)
epidural/spinal catheters
inline filters
syringes (2-100 ml)
neuraxial extension sets
neuraxial infusion pump sets
loss of resistance syringes
intracranial pressure monitor
CONNECTIONS for access to urinary catheters ISO 80369-4
the urinary tract
ureteric catheters
urine collecting system tubing
CONNECTIONS for access to venous access port ISO 80369-7
arterial and venous vascular
systems central venous catheter NOTE Upon its
publication, ISO 80369-7:—
CONNECTIONS for arterial pressure lines will replace ISO 594-1:1986
subcutaneous, intra- and ISO 594-2:1998.
diagnostic catheter
muscular and intraperitoneal
injections and infiltrations extracorporeal devices
MEDICAL DEVICES intended to
connect to syringes
13
BS EN ISO 80369-1:2010
ISO 80369-1:2010(E)

Annex D
(informative)

Reference to the Essential Principles

This part of ISO 80369 has been prepared to support the essential principles of safety and performance of
SMALL-BORE CONNECTORS as components of MEDICAL DEVICES as listed in ISO/TR 16142:2006, Table A.1. This
part of ISO 80369 is intended to be acceptable for conformity assessment purposes.

Compliance with this part of ISO 80369 provides one means of demonstrating conformance with the specific
essential principles of ISO/TR 16142:2006. Other means are possible. Table D.1 shows the correspondence
between the clauses and subclauses of this part of ISO 80369 and the essential principles of safety and
performance of MEDICAL DEVICES as listed in ISO/TR 16142:2006, Table A.1.

14 © ISO 2010 – All rights reserved

 BS EN ISO 80369-1:2010
ISO 80369-1:2010(E)

Table D.1 — Correspondence between this document and the essential principles

Essential principles listed in Corresponding clause(s)/

Qualifying remarks/Notes
ISO/TR 16142:2006, Table A.1 subclause(s) of this part of ISO 80369
A.1, A.2 all
A.3 – Not applicable
A.4 – Not applicable
A.5 – Not applicable
A.6 – Not applicable
A.7.1 – Not applicable
A.7.2 – Not applicable
A.7.3 – Not applicable
A.7.4 – Not applicable
A.7.5 4, 5, 6
A.7.6 4, 5, 6
A.8.1 – Not applicable
A.8.1.1 – Not applicable
A.8.1.2 – Not applicable
A.8.2 – Not applicable
A.8.3 – Not applicable
A.8.4 – Not applicable
A.8.5 – Not applicable
A.8.6 – Not applicable
A.9.1 4, 5, 6
A.9.2 – Not applicable
A.9.3 – Not applicable
A.10.1 – Not applicable
A.10.2 – Not applicable
A.10.3 – Not applicable
A.11.1.1 – Not applicable
A.11.2.1 – Not applicable
A.11.2.2 – Not applicable
A.11.3 – Not applicable
A.11.4 – Not applicable
A.11.5.1 – Not applicable
A.11.5.2 – Not applicable
A.11.5.3 – Not applicable
A.12.1 – Not applicable
A.12.2 – Not applicable
A.12.3 – Not applicable
A.12.4 – Not applicable
A.12.5 – Not applicable
A.12.6 – Not applicable
A.12.7.1 – Not applicable
A.12.7.2 – Not applicable
A.12.7.3 – Not applicable
A.12.7.4 4, 5, 6
A.12.7.5 – Not applicable
A.12.8.1 – Not applicable
A.12.8.2 – Not applicable
A.12.8.3 – Not applicable
A.13.1 – Not applicable
A.14.1 – Not applicable

© ISO 2010 – All rights reserved 15

BS EN ISO 80369-1:2010
ISO 80369-1:2010(E)

Bibliography

[1] ISO 8185:2007, Respiratory tract humidifiers for medical use — Particular requirements for respiratory
humidification systems

[2] ISO 14971:2007, Medical devices — Application of risk management to medical devices

[3] ISO 5359:2008, Low-pressure hose assemblies for use with medical gases

[4] ISO/TR 16142:2006, Medical devices — Guidance on the selection of standards in support of
recognized essential principles of safety and performance of medical devices

[5] IEC 60601-1:2005, Medical electrical equipment — Part 1: General requirements for basic safety and
essential performance

[6] CEN CR 13825, Luer connectors — A report to CEN chef from the CEN forum task group “Luer
fittings”

[7] Global Harmonization Task Force (GHTF) — Study Group 1 (SG1), Document No. N029R11, dated
2 Feb. 2002

[8] Tackling Tube Misconnections, The Wall Street Journal, 27 June 2007,
http://online.wsj.com/article/SB118289594893449089.html?mod=yahoo_hs&ru=yahoo

[9] Medical Misconnections Day 1: A common medical mistake, Wisconsin State Journal, 12 July 2007
http://www.madison.com/wsj/home/local/index.php?ntid=198536

[10] Groups Work to Eliminate Medical Errors From Tube Misconnections, Medical News Today,
29 June 2007 http://www.medicalnewstoday.com/articles/75466.php

[11] Problems Persist with Life-Threatening Tubing Misconnections, ISMP Medication Safety Alert,
17 June 2004 http://www.ismp.org/newsletters/acutecare/articles/20040617.asp

[12] Tubing misconnections — a persistent and potentially deadly occurrence, Sentinel Event Alert,
The Joint Commission, 3 April 2006
http://www.jointcommission.org/SentinelEvents/SentinelEventAlert/sea_36.htm

[13] Enteral Feeding Misconnections, Technical Paper,

http://www.baxa.com/OnlineHelp/Technical%20Papers/Enteral%20Misconnections%20Technical%20
Paper.pdf

[14] Misconnection of Vitrectomy Handpieces and Vitrectomy Units, ECRI Institute’s Medical Device Safety
Reports, February 1995 http://www.mdsr.ecri.org/summary/detail.aspx?doc_id=8211

[15] Tracheal Cuff Inflation Tube Mistaken for Enteral Feeding Tube, ECRI Institute’s Medical Device
Safety Reports, February-March 1986 http://www.mdsr.ecri.org/summary/detail.aspx?doc_id=8148

[16] ASTM D747-10, Standard test method for apparent bending modulus of plastics by means of a
cantilever beam

[17] ASTM D790-10, Standard test methods for flexural properties of unreinforced and reinforced plastics
and electrical insulating materials

16 © ISO 2010 – All rights reserved

 BS EN ISO 80369-1:2010
ISO 80369-1:2010(E)

Terminology – Alphabetized index of defined terms

ACCESSORY ....................................................................................................................................................... 3.1

APPLICATION ...................................................................................................................................................... 3.2
BREATHING SYSTEM ............................................................................................................................................3.3
CONNECTION ..................................................................................................................................................... 3.4
CONNECTOR ...................................................................................................................................................... 3.5
HARM ............................................................................................................................. 2.2 of ISO 14971:2007
HAZARD ............................................................................................................................. 2.3 of ISO 14971:2007
HAZARDOUS SITUATION ....................................................................................................... 2.4 of ISO 14971:2007
INTENDED USE ................................................................................................................... 2.5 of ISO 14971:2007
MANUFACTURER ................................................................................................................ 2.8 of ISO 14971:2007
MEDICAL DEVICE ................................................................................................................. 2.9 of ISO 14971:2007
NON-INTERCONNECTABLE ................................................................................................................................... 3.6
OBJECTIVE EVIDENCE ....................................................................................................... 2.10 of ISO 14971:2007
PATIENT ............................................................................................................................................................. 3.7
PROCEDURE .................................................................................................................... 2.12 of ISO 14971:2007
PROCESS ......................................................................................................................... 2.13 of ISO 14971:2007
RECORD .......................................................................................................................... 2.14 of ISO 14971:2007
RESPONSIBLE ORGANIZATION ............................................................................................................................. 3.8
RISK ........................................................................................................................... 2.16 of ISO 14971:2007
RISK ANALYSIS ................................................................................................................. 2.17 of ISO 14971:2007
RISK MANAGEMENT .......................................................................................................... 2.22 of ISO 14971:2007
RISK MANAGEMENT FILE .................................................................................................... 2.23 of ISO 14971:2007
RIGID MATERIAL .................................................................................................................................................. 3.9
SEMI-RIGID MATERIAL ....................................................................................................................................... 3.10
SEVERITY ........................................................................................................................ 2.25 of ISO 14971:2007
SMALL-BORE .................................................................................................................................................... 3.11
USABILITY ......................................................................................................................... 3.17 of IEC 62366:2007
USER ............................................................................................................................ 3.23 of IEC 62366:2007
USER INTERFACE ............................................................................................................... 3.24 of IEC 62366:2007
USER PROFILE ................................................................................................................... 3.25 of IEC 62366:2007
VERIFICATION ................................................................................................................... 2.28 of ISO 14971:2007

© ISO 2010 – All rights reserved 17

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